Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
Reported: October 6, 2021 Initiated: September 21, 2021 #D-0898-2021
Product Description
Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
Reason for Recall
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Details
- Recalling Firm
- SigmaPharm Laboratories LLC
- Units Affected
- 1192 bottles
- Distribution
- Nationwide
- Location
- Bensalem, PA
Frequently Asked Questions
What product was recalled? ▼
Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14. Recalled by SigmaPharm Laboratories LLC. Units affected: 1192 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 6, 2021. Severity: Moderate. Recall number: D-0898-2021.
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